The present invention relates, generally, to the field of electrocardiography. Specifically, the present invention relates to an electrocardiograph harness carrying a multiple of electrodes which when electrically connected to an electrocardiograph recording apparatus receive, transmit and record valuable electrical information about a patient's health and, in particular, the health and condition of the patient's heart.
Electrocardiograph harnesses are now available which carry the required number of electrodes for chest area and limbs. They suffer, however, from various disadvantages. For example, the prior art harnesses are incapable of being easily adapted to both large adults and then to small children. Rather, however, the prior art harnesses are provided in different sizes and the size of the patient dictates the selected size of the harness. This, however, in an emergency room environment, where time is critical, can clearly cause problems. The present invention enables the doctor or technician to quickly and accurately "grossly" mold the harness to the size and shape of the patient and then to "fine tune" the location of the electrodes on the harness since they are slidably adjustable.
The electrodes of the prior art are generally attached and held to the patient's body by either suction cups and/or an electrolytic gel or paste which both establish good electrical and adhesive contact between the electrodes and the patient's skin. However, it is quite frequent that the suction, over time, of the electrodes diminishes to the point where the electrodes fall off of the patient and/or the gel or paste losses its adhesiveness such that the electrodes become detached from the patient. Again, in an emergency room situation, this is highly undesirable. Even in a doctor's office, the recording of the health and strength of the heart is a very high anxiety producing medical procedure, which anxiety is raised when the patient recognizes that the electrodes have become disengaged from his or her body. The present electrode harness, as will be more fully explained hereinafter, firmly secures the electrodes to the patient's skin by enhancing the otherwise available attachment by suction and/or electrolytic paste or gel with the downwardly biased weight of an electrode-carrying tube, containing the electrode lead wires and the weight of a contained stylet. This further ensures that the electrodes will be maintained in place.
Multiple electrodes are also available for use with an electrocardiograph recording apparatus where the individual electrodes are connected, by rather long lead wires to a central electrical signal distribution box-like structure. The technician who is charged with the responsibility of readying the patient for the cardiac recording procedure is expected to quickly and accurately attach each electrode, in a particular order, to the patient, in a minimum of time. Because of the time pressure, again in medical emergency situations where a heart attack or stroke is a possibility, or even in the doctor's office, during a routine medical check up, where the technician is inattentive, the electrodes can quite easily be accidentally switched in order and a false and misleading recording of the patient's health and heart condition can result. Clearly, this, too, is highly undesirable. The present invention, in contrast, pre-locates the individual electrodes, in the proper order for recording, in their approximate, desired location so that false readings and recordings are eliminated. Adjacent electrodes, connected to the recording apparatus, can no longer be accidentally switched in position. Also, the electrical plug which connects the harness and the individual electrodes to the recording apparatus is uniquely shaped so that it can only be plugged into the recording apparatus in a precise manner to result in accurate "tracings" or recordings.
Basically, the general concept of the present invention relates to an apparatus for simply, quickly and efficiently readying a patient for an electrocardiograph test procedure. The apparatus is intended to be electrically connected to an existing electrocardiograph recording machine. The lead wires for the electrodes, which are normally individually wired back to the recording apparatus, are passed through a hollow conduit which eliminates the possibility of accidental switching of the order of the electrodes. Furthermore, the conduit which carries the wires for the electrodes also carries a flexible metal-like rod (a stylet) which can be repeatedly bent to a size and shape for a particular patient, will hold the newly formed shape and, yet, can be rebent to a new size and shape for a different patient. This allows the apparatus to be used over and over again, and, yet, gives the technician the ability to simply and quickly form or shape the hollow conduit to the particular physical characteristics of the patient. Also, the weight of the stylet, contained within the conduit, enhances the tendency of the electrodes, carried by the conduit, to be weighted or downwardly biased towards the patient's skin for superior electrical contact.
It is another aspect of the present invention for the individual electrodes to be longitudinally adjustably slidable along the length of the conduit while, however, always remaining electrically connected to the recording apparatus. This, too, gives the technician flexibility in adapting, molding, shaping, etc., the device to the physical size, shape, location of heart, etc., characteristics of the patient. This aspect of the invention is accomplished by the use of spring-like clips attached to the electrodes. When the ears of the clips are squeezed together, the electrodes are capable of being horizontally adjusted along the length of the tube and when the ears of the clips are released, the electrodes will be precisely located along the length of the conduit.
The following prior art was uncovered and reviewed pursuant to a preliminary patentability search.
______________________________________ U.S. Pat. No. Date Inventor ______________________________________ 4,608,987 09/02/86 Mills 4,583,549 04/22/86 Manoli 4,573,474 03/04/86 Scibetta 4,353,382 10/12/82 Ayer 4,328,814 05/11/82 Arkans 4,233,987 11/18/80 Feingold ______________________________________
The Arkans reference appears to be the closest teaching uncovered in the search. It shows an ECG strip with a plurality of electrodes attached thereto. The wiring for the electrodes are held together to avoid entangling with one another. The electrodes are somewhat horizontally adjustable along the strip and the electrodes' wires terminate at a single common electrical male member. However, there is no teaching of a flexible stylet housed in the conduit which contains the individual electrical leads for the electrodes, the stylet providing both weighting of the electrodes onto the patient's skin and, in addition, allowing the harness to be "molded" and shaped to the patient's chest size and shape. The stylet enables the tube or conduit of the harness to be grossly shaped, as desired. The stylet holds that shape until molded again for use on another patient. Also, the spring clips which are used for precisely locating and adjusting the electrodes are far easier and more "sure to the touch" than the manner of doing the same as shown in the Arkans device. Release of the ears of the spring clips, after placement of the electrodes, ensures no further movement of the electrodes, while the electrodes of Arkans can easily move, even after placement.
In addition, the Arkans reference's device does not appear to be able to hold onto perspiring or restless patients, while the present invention, by the simple use of leather straps located below the patient's right shoulder and left hip (left upper quadrant) prevents accidental movement of the electrodes. Also, if electrode gel spills or gets smeared during the diagnostic procedure, it is far easier to clean the same from the plastic tubing of the present invention than it would be to clean the Arkans device. Finally, with respect to Arkans, it does not appear to be useful for pediatric use since the electrodes do not appear to be able to slide close enough together for small chest sizes. Here, again, the present invention is quite flexible and moldable to both large and small patient chest sizes, whether skinny or fat.
The Mills reference relates to an apparatus for transmitting ECG data and comprises a vest-like garment having a plurality of apertures adapted for receiving electrodes. According to the specification of the patent, the individual electrodes are downwardly biased against the front panel of the vest and towards the skin surface of the patient to provide better electrical contact. The specification further provides that it is an additional feature of the invention to have each electrode in a fixed position relative to other electrodes. There is neither a teaching nor a suggestion of using a hollow conduit containing the individual electrode lead lines (which decreases patient anxiety and avoids entanglement between the leads) nor of having a shapable stylet contained therein for molding the harness to individual patient's chest size and shape, thereby resulting in an apparatus which efficiently and precisely places and locates multiple electrodes, thereby eliminating the possibility of switching one electrode for another. The Mills reference really does not teach a means for ensuring that electrodes and their "leads" do not become switched and, in addition, the electrodes are not adjustably held by the vest (in contrast to the present invention's horizontally adjustable electrodes) but, rather, the electrodes of Mills merely pass through apertures of the vest and are connected to the electrical leads. The downward biasing of the device in Mills is accomplished by a compression providing member (a spring) and not a moldable stylet. The stylet of the present invention, however, also allows the harness to be grossly molded to the patient's physique. Fine adjustment of the electrodes is accomplished by sliding them on the length of the tube. Finally, Mills's device is a closed vest, which is more constraining and anxiety producing than a simple conduit overlying the patient's chest and, again, in emergency medical situations, it is far easier to "fit" the patient with the harness than to clothe a patient with a vest.
The Manoli device relates to an ECG electrode pad made from flexible non-conductive material with a plurality of electodes fixedly placed thereon. Again, in contrast, the present harness allows for precise adjustment of the electrodes by the spring clips. Manoli and Mills state that three sizes of their devices should be capable of handling most sized patients. Contrarily, one harness of the present invention can handle most sized patients. Thus, the present device can eliminate the requirement for a plurality of devices to be readily available. Also, the Manoli device has little flexibility to conform to truly different shapes since the pad has the wiring etched thereon and the pad is not capable of significant molding or shaping.
The Scibetta reference relates to a cable harness for an ECG device. Its primary purpose and function is to enable monitoring of heart activity and, yet, when required, the entire central portion, with its electrodes, can be simply removed, in an instant, to allow heart massage, if required. The "booms" of the device, through which the electrodes pass, are not flexible and, therefore, do not truly provide the degree of flexibility and ability to mold to the patient's size and shape, which the hollow tube with stylet contained therein provides. Also, the present harness device is much more "open" and less anxiety producing to a patient since it is less constraining. The Scibetta reference does, however, seem to show a plurality of electrodes exiting through a boom arm with the wiring internally confined within the arm. There is no teaching, however, of having the arm, itself, provide any downward biasing or weight to enhance electrode contact with the patient's skin and, indeed, the use of suspended arms over the patient's chest area teaches away from the direct downward pressure which the stylet contained within a tube having electrode lead wires provides.
The Ayer reference is for a medical cable set and electrodes. There is no teaching of a flexible, weight-providing stylet contained within the harness's tube nor of having a moldable stylet for gross shaping to the patient's size and shape. Also, the spring clips of the present invention give unique fine location of the electrodes and, once located, fixedly hold them in place. The electrodes of Ayer can be first positioned but, then, can easily shift on the patient since they are not, in any way, held or constrained in place. Ayer does, however show a common male plug member for plugging into the ECG recorder, but it is symmetrically shaped and, therefore, it can accidentally be flipped over to be plugged into the recorder with the electrodes thus providing incorrect information. The uniquely shaped male plug member of the present invention is designed to only be able to be inserted into the female receptacle in but one manner, thereby precluding inaccurate connection between an electrode and the recording instrument, which could then be interpreted by the doctor or technician, with potentially disastrous results.
The Feingold reference is quite similar to the pad shown in the Manoli patent but, here, the pad can be selectively torn to provide a little more flexibility in electrode placement. It is far easier to use the present invention's spring-like clips to place the electrodes accurately than it appears it would be for the technician to rip the pad and then place the electrodes of Feingold. The ease of use of the present harness is clearly superior to that shown in Feingold. Also, the present invention can be repeatedly used on patient after patient, whereas a ripping of Feingold renders the device inapplicable to a different size or shape patient.